Data updated: May 26, 2026
DULOXETINE HYDROCHLORIDE
Trial Activity: Declining 18 active trials
CNS
Approved 2013-12-11
Development Insights
Eli Lilly and Company conducting 26 trials (22%)
92 indications explored (Broad Platform)
→ major depressive disorder (17 trials)
→ depression (13 trials)
→ healthy (6 trials)
16
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-12-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, CAPSULE, DELAYED RELEASE
Companies
Sun Pharma WOCKHARDT Aurobindo Pharma Apotex INVENTIA MACLEODS PHARMS LTD ADAPTIS ZYDUS PHARMS Teva IMPAX LABS INC Lupin CSPC OUYI ZYDUS HLTHCARE Novartis ALEMBIC YAOPHARMA CO LTD ALMATICA ALKEM LABS LTD PRINSTON INC AJANTA PHARMA LTD TORRENT QINGDAO BAHEAL PHARM PH HEALTH BRECKENRIDGE HETERO LABS LTD III SUNSHINE
Active Ingredient: DULOXETINE HYDROCHLORIDE
Website: ↗
DULOXETINE HYDROCHLORIDE Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
459 FDA actions from 2013 to 2026
Apr 2026 SUPPL
Mfg · Manufacturing (CMC)
Mar 2025 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label
Feb 2025 SUPPL
Label
Dec 2024 SUPPL
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Oct 2024 SUPPL
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May 2024 SUPPL
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Feb 2024 SUPPL
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Jan 2024 SUPPL
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Dec 2023 SUPPL
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Dec 2023 SUPPL
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Jun 2023 SUPPL
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May 2023 SUPPL
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Jul 2022 SUPPL
Label
Jul 2022 SUPPL
Mfg
Jan 2022 SUPPL
Label
Feb 2021 ORIGINAL
Update
Dec 2020 SUPPL
Mfg
Dec 2020 SUPPL
Label
Dec 2019 SUPPL
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Aug 2019 SUPPL
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Aug 2019 ORIGINAL
Update
May 2019 SUPPL
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Apr 2019 ORIGINAL
Update
Oct 2018 ORIGINAL
Update
Jul 2018 SUPPL
Label
May 2018 SUPPL
Update
Jul 2017 SUPPL
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May 2017 ORIGINAL
Update
Apr 2017 SUPPL
Mfg
Mar 2017 ORIGINAL
Update
Jan 2017 ORIGINAL
Update
Aug 2016 ORIGINAL
Update
Dec 2015 SUPPL
Mfg
Dec 2015 SUPPL
Label
Oct 2015 ORIGINAL
Update
Sep 2015 SUPPL
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Aug 2015 ORIGINAL
Update
Dec 2014 SUPPL
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Dec 2014 SUPPL
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Sep 2014 SUPPL
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Jun 2014 ORIGINAL
Update
Jun 2014 ORIGINAL
Update
Mar 2014 SUPPL
Label
What DULOXETINE HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 2013 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Dec 2013)Letter
- • Approved indication (Dec 2013)Letter
- • Approved indication (Jan 2014)Letter
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2014)
- • Approved indication (Aug 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Aug 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Mar 2017)
- • Approved indication (May 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Apr 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Feb 2026) NewLetter
📋
Clinical Trial Registry
123 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07431606 Duloxetine in | 859508 | Ph 2 | not yet recruiting | Duloxetine in Inflammatory Bowel Diseases |
| NCT06245109 PREDICT | STU00219434 | Ph 4 | recruiting | Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis |
| NCT06614322 | STUDY00009806 | Ph 2 | recruiting | SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy. |
| NCT04504812 SKOAP | IRB00238678 1UG3AR077360-01 | Ph 3 | completed | A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain |
| NCT05840562 CAPNEUCHIM | ICO-2022-02 | Ph 3 | recruiting | Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy |
| NCT06807866 | 20240579 | Ph 4 | recruiting | Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT |
| NCT05814640 STAR-AD | 1stChongqingMU--ZXY | Ph 1, Ph 2 | recruiting | Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) |
| NCT04137107 | A221805 NCI-2019-04727 | Ph 2, Ph 3 | active not recruiting | Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer |
| NCT04560673 | 2019-0712 NCI-2020-06553, 2019-0712 | Ph 2 | recruiting | Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy |
| NCT06423716 RELIFE | SBK 6156 | Ph 4 | recruiting | Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE) |
| NCT04870957 BACPAC results posted | HUM00180994 1U19AR076734-01 | Ph 4 | completed | The Back Pain Consortium Research Program Study |
| NCT05851976 | 2023-14971 | Ph 4 | recruiting | Duloxetine for LBP |
| NCT06860984 | 5487 | Ph 3 | recruiting | Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis |
| NCT05086393 | 19081605 | Ph 4 | completed | Duloxetine RCT on Postop TKA Outcomes |
| NCT03548454 results posted | 44758 | Ph 4 | completed | Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization |
| NCT04395001 PRECICE results posted | IRB00065428 1UG3NR019196-01 | Ph 4 | completed | Pain Response Evaluation of a Combined Intervention to Cope Effectively |
| NCT04111627 | HP-00089160 K01AG064041 | Ph 2 | completed | Exercise Plus Duloxetine for Knee Osteoarthritis |
| NCT05396014 BEST results posted | 21-1972 1U24AR076730 | Ph 4 | completed | The BEST Trial: Biomarkers for Evaluating Spine Treatments |
| NCT03852160 | CR108567 2018-001890-26, 54135419TRD3011 | Ph 3 | withdrawn | A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression |
| NCT05786599 METACIN | H22-01702 | Ph 2, Ph 3 | recruiting | Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy |
| NCT03249558 Duloxetine results posted | 2017P001589 | Ph 4 | completed | Effect of Combined Morphine and Duloxetine on Chronic Pain |
| NCT04970121 | BYEC20210701 | Ph 2 | recruiting | Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy |
| NCT06606067 GENDOLCAT3 | ICI21 / 00006 2022-001354-29 | Ph 3 | active not recruiting | Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk |
| NCT06551051 | CIPN-ADC-001 | Ph 2 | recruiting | ADC-induced Neurotoxicity Treated With Duloxetine |
| NCT04245748 DOTS-AD | Strawn DOTS-AD | Ph 4 | recruiting | Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD) |
| NCT04245436 AtLAS-A | Strawn AtLAS-A | Ph 4 | recruiting | Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A) |
| NCT06232473 EDULOX | 9515 | Ph 4 | recruiting | Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder |
| NCT04476030 results posted | 217-MDD-305 | Ph 3 | completed | A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder |
| NCT04117893 | KY 2019-086-02 | Ph 4 | completed | Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients |
| NCT03068247 | 00095062 | Ph 3 | withdrawn | Neurobiology of Treatment Responses in MDD |
| NCT04178993 results posted | BED(IN):40 R01DA047391 | Ph 1 | completed | Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine] |
| NCT01598298 results posted | S1202 S1202, U10CA037429 | Ph 3 | completed | S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy |
| NCT04639011 | H-40569 | Ph 4 | withdrawn | Duloxetine Tibial Plateau |
| NCT04412876 | 109017-F | Ph 3 | withdrawn | Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study |
| NCT05115123 | 23-2021 | Ph 2 | completed | Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy |
| NCT04697693 results posted | 8111 | Ph 4 | terminated | Antidepressant Response in Older Adults With Comorbid PTSD and MDD |
| NCT04246619 BLOSSOM | KCT 11/2017 2017-004341-24 | Ph 4 | terminated | Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life |
| NCT05296759 | 2217 | Ph 4 | completed | Botulinum Toxin Type A in Diabetic Peripheral Neuropathy |
| NCT02174822 | 14-AVP-786-101 | Ph 1 | completed | A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects |
| NCT04224584 | DULKOA2019 | Ph 2 | completed | A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain |
| NCT00863057 results posted | A5252 10636, ACTG A5252 | Ph 2 | terminated | Combination Pain Therapy in HIV Neuropathy |
| NCT03395353 results posted | 16916 F1J-JE-HMHF, 1702A3632 | Ph 3 | terminated | A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder |
| NCT01754493 IBS-MDD results posted | #6479R F1J-US-X037 | Ph 4 | completed | Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression |
| NCT01846182 REGIONS results posted | SPLD-016-12F 6125 | Ph 2 | terminated | Research Examining Gulf War Illness in Our Nations Service Members |
| NCT04532684 | ozgeilleez | Ph 4 | completed | Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain |
| NCT03315793 results posted | 14937 F1J-JE-B058, 1701A3631 | Ph 3 | completed | A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder |
| NCT03037073 | Duloxetine POM | Ph 2, Ph 3 | completed | Duloxetine for Succinylcholine-induced Postoperative Myalgia |
| NCT04388189 LEAP-DB | LEAP-DB | Ph 4 | withdrawn | Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion |
| NCT02535000 Duloxetine results posted | 1 | Ph 4 | completed | Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery |
| NCT01912612 results posted | UMCC 2013.044 HUM00075181, HCI94979 | Ph 2 | completed | Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain |
Showing 50 of 123 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DULOXETINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment